CN114632108B - Composition paste, preparation method and application thereof - Google Patents

Abstract

The application provides a composition paste, a preparation method and application thereof. Wherein the composition paste is used for treating hormonal dermatitis. The composition paste is prepared by mixing white vaseline, lanoline, azone, and glycerol, and heating to dissolve completely to obtain a first composition. Then, the gentian, the radix sanguisorbae, the kuh-seng, the moutan bark, the lithospermum and the liquorice are mixed according to a preset proportion, and then are subjected to superfine grinding, and are sieved to obtain the traditional Chinese medicine fine powder. And finally, adding the traditional Chinese medicine fine powder into the first composition, stirring until the mixture is uniform, and standing and cooling to obtain the composition paste. Furthermore, the preparation process of the composition ointment is simple, the safety is high, and the characteristics of external treatment of traditional Chinese medicine are reflected. Meanwhile, the ointment provided by the application fully plays the curative effect of the traditional Chinese medicine, effectively reduces the inflammatory reaction of the hormone-dependent dermatitis, and has obvious effects on repairing the skin barrier function, promoting the metabolism of the horny layer cells and the like.

Description

Composition paste, preparation method and application thereof

Technical Field

The application relates to the technical field of preparation and application of pharmaceutical preparations, in particular to a composition paste, a preparation method and application thereof.

Background

The hormone-dependent dermatitis (hormone dependence dermatitis, HDD) refers to a glucocorticoid preparation for long-term external use on skin, and once the skin stops taking medicines, the original skin diseases recur and aggravate, and the non-suppurative and inflammatory skin diseases are caused. Typical clinical features are: the skin rash is improved rapidly after the glucocorticoid is applied, the skin rash is recurrent and aggravated rapidly once the drug is stopped, erythema, pimple, purpura, pigmentation, desquamation, dryness, acne or rosacea dermatitis and the like can be seen, and skin atrophy and telangiectasia can occur in serious patients, and the skin can be accompanied with obvious discomfort such as local pruritus, burning and the like.

At present, although the methods for treating the hormone-dependent dermatitis are more, aiming at the situation that the disease recurs and even aggravates after hormone deactivation, the clinic always lacks an efficient treatment means, and the method becomes a difficult problem in treatment. The traditional Chinese medicine has unique advantages in the aspect of treating skin diseases, especially external treatment, and the traditional Chinese medicine preparation have small side effects, are simple, convenient and cheap to prepare, and have outstanding curative effects. Therefore, the application provides the composition ointment, which fully plays the curative effect of the traditional Chinese medicine, effectively reduces inflammatory reaction, and has obvious effects on repairing skin barrier function, promoting keratinocyte metabolism and the like.

Disclosure of Invention

In view of the above, the application provides a composition paste, a preparation method and application thereof, and the composition paste fully exerts the curative effect of traditional Chinese medicines, effectively reduces the inflammatory response of hormone-dependent dermatitis, and has obvious effects on repairing the skin barrier function, promoting the metabolism of keratinocytes and the like.

In a first aspect, the present application provides a composition paste for use in the treatment of hormonal dermatitis comprising the following components: 10-40% of traditional Chinese medicine fine powder, 45-70% of white vaseline, 9-14% of lanoline, 2% of azone and 4% of glycerin.

Optionally, the traditional Chinese medicine fine powder comprises the following components: the ratio of gentian to radix sanguisorbae to radix sophorae flavescentis to cortex moutan to lithospermum to liquorice is 1.5 to 0.3 to 1.0.

In a second aspect, the application provides the use of a composition paste for the treatment of hormone dependent dermatitis.

In a third aspect, the application provides a method for preparing a composition paste, comprising the steps of:

mixing white vaseline, lanolin, azone, and glycerol, and heating to dissolve completely to obtain a first composition;

mixing radix Gentianae, radix Sangusorbae, radix Sophorae Flavescentis, cortex moutan, radix Arnebiae and Glycyrrhrizae radix at a preset ratio, micronizing, pulverizing, and sieving to obtain Chinese medicinal fine powder;

adding the traditional Chinese medicine fine powder into the first composition, stirring until uniform, standing and cooling to obtain composition paste.

According to the technical scheme, the application provides a composition paste, a preparation method and application thereof. Wherein the composition paste is used for treating hormonal dermatitis. The composition paste is prepared by mixing white vaseline, lanoline, azone, and glycerol, and heating to dissolve completely to obtain a first composition. Then, the gentian, the radix sanguisorbae, the kuh-seng, the moutan bark, the lithospermum and the liquorice are mixed according to a preset proportion, and then are subjected to superfine grinding, and are sieved to obtain the traditional Chinese medicine fine powder. And finally, adding the traditional Chinese medicine fine powder into the first composition, stirring until the mixture is uniform, and standing and cooling to obtain the composition paste. Furthermore, the preparation process of the composition ointment is simple, the safety is high, and the characteristics of external treatment of traditional Chinese medicine are reflected. Meanwhile, the ointment provided by the application fully plays the curative effect of the traditional Chinese medicine, effectively reduces the inflammatory reaction of the hormone-dependent dermatitis, and has obvious effects on repairing the skin barrier function, promoting the metabolism of the horny layer cells and the like.

Drawings

In order to more clearly illustrate the technical solution of the present application, the drawings that are needed in the embodiments will be briefly described below, and it will be obvious to those skilled in the art that other drawings can be obtained from these drawings without inventive effort.

FIG. 1 is a schematic diagram of a technical route provided by the present application;

FIG. 2 is a schematic representation of the change in skin microscopy before and after composition paste intervention in guinea pig HDD;

fig. 3 is a schematic diagram of the pathological results of HE staining of skin tissue provided by the application.

Detailed Description

Reference will now be made in detail to the embodiments, examples of which are illustrated in the accompanying drawings. When the following description refers to the accompanying drawings, the same numbers in different drawings refer to the same or similar elements, unless otherwise indicated. The embodiments described in the examples below do not represent all embodiments consistent with the application. Merely exemplary of systems and methods consistent with aspects of the application as set forth in the claims.

In a first aspect, the present application provides a composition paste for use in the treatment of hormonal dermatitis comprising the following components: 10-40% of traditional Chinese medicine fine powder, 45-70% of white vaseline, 9-14% of lanoline, 2% of azone and 4% of glycerin.

Wherein the traditional Chinese medicine fine powder comprises the following components: the ratio of gentian to radix sanguisorbae to radix sophorae flavescentis to cortex moutan to lithospermum to liquorice is 1.5 to 0.3 to 1.0.

Experiments prove that when the content of the traditional Chinese medicine fine powder is more than or equal to 20%, the traditional Chinese medicine fine powder has obvious curative effect on the hormone-dependent dermatitis, and the ointment has good formability and spreadability, so that the optimal proportion of the ointment is finally determined as follows: 20% of traditional Chinese medicine fine powder, 61% of white vaseline, 13% of lanoline, 2% of azone and 4% of glycerin.

Therefore, the composition ointment provided by the application is specifically a sanguisorba ointment, and the sanguisorba ointment consists of 20% of traditional Chinese medicine fine powder, 61% of white vaseline, 13% of lanolin, 2% of azone and 4% of glycerin. The Chinese medicinal components of the garden burnet ointment have the effects of clearing heat and drying dampness, cooling blood and detoxifying, have remarkable effects on improving erythema, pimple, swelling, scales, itching, burning sensation, pain, tightness and the like, can effectively relieve inflammatory reaction, reduce exudation, and have remarkable effects on repairing skin barrier function, promoting keratinocyte metabolism and the like.

In a second aspect, the application provides the use of a composition paste for the treatment of hormone dependent dermatitis.

In order to confirm that the composition paste has the above new application, the present application has been conducted as follows.

1. Grouping and modeling of experimental animals

50 normal healthy male guinea pigs are tested, and all white short hairs are male, and the weight is 280+/-20 g.

The randomization was divided into 6 groups: normal control (a), blank (B), experimental low dose (10% sanguisorba ointment, C), experimental medium dose (20% composition ointment, D), experimental high dose (40% composition ointment, E), positive control (tacrolimus ointment, F), 8 groups except 10 blank.

The back of each guinea pig was used as an experimental area with a size of 5 x 5cm, and hair was removed. Except for the normal control group, 75% alcohol is coated, the other 5 groups are firstly molded, namely: the local skin of the back of the guinea pig is externally coated with the clobetasol propionate tincture with the concentration of 0.05 percent, the skin is massaged for 1 to 2 times a day until the skin is fully absorbed, the skin is continuously absorbed for 49 days, 2 to 5 days after stopping the drug, 2 materials are randomly extracted from a blank control group, and whether the model is successful or not is detected.

7 days after stopping the drug, the group B is externally coated with vaseline at the original skin lesion, the group C is externally coated with 10% of the composition paste, the group D is externally coated with 20% of the composition paste, the group E is externally coated with 40% of the composition paste, and the group F is externally coated with tacrolimus paste, 2 times a day for 21 days.

2. Composition paste preparation

The Chinese medicinal fine powder is prepared by mixing radix Gentianae, radix Sanguisorbae, radix Sophorae Flavescentis, cortex moutan, radix Arnebiae and Glycyrrhrizae radix at a ratio of 1.5:1.5:0.3:1.0:1.0:1.0, pulverizing, and sieving with 100 mesh sieve.

Wherein, the 10% composition paste (low dose) is specifically an ointment low dose group, and is prepared by the following steps: taking all the materials according to the proportion of each component, namely 70 percent of white vaseline, 14 percent of lanoline, 2 percent of azone and 4 percent of glycerin. Heating to dissolve completely, adding 10% of the Chinese medicinal fine powder, stirring, packaging in bottle, cooling, and storing in refrigerator at 4deg.C.

20% of the composition paste (medium dose) is specifically an ointment medium dose group, formulated: taking the substances according to the proportion of the components, namely 61% of white vaseline, 13% of lanoline, 2% of azone and 4% of glycerin. Heating to dissolve completely, adding 20% of the Chinese medicinal fine powder, stirring, packaging in bottle, cooling, and storing in refrigerator at 4deg.C.

40% composition paste (high dose) specifically an ointment high dose group, formulated: taking the materials according to the proportion of the components, namely 45 percent of white vaseline, 9 percent of lanoline, 2 percent of azone and 4 percent of glycerin. Heating to dissolve completely, adding 40% of the Chinese medicinal fine powder, stirring, packaging in bottle, cooling, and storing in refrigerator at 4deg.C.

3. Detection method

(1) Staining of skin tissue

Skin tissue at each skin lesion was excised approximately 0.5cm x 0.5cm in size and fixed with 4% paraformaldehyde for 16-24 hours. Sequentially adding 70% alcohol 0.5 hr, 80% alcohol 0.5 hr, 90% alcohol 0.5 hr, 95% alcohol 0.5 hr×2 times, 100% alcohol 20min×2 times, and xylene transparent 15min×2 times; wax dipping for 1h multiplied by 2 times; embedding the embedding box, slicing with 5um, spreading and baking, and then performing HE dyeing. The changes of the tissue structure, morphology, skin thickness, etc. of each group of local skin lesions were observed.

(2) Detection index

Immunohistochemical method to detect silk-polymerized protein, intein, etc. in skin damaged epidermis. Skin loss, oil and skin loss (TWEL) were measured.

4. Experimental results

4.1 detection of skin moisture content of Sanguisorba ointment before and after intervention of guinea pig HDD

The results of the detection of HDD model guinea pigs using sebum detectors before and after treatment are shown in table 1. The water content and the oil content of the model group are reduced compared with those of the blank group, and the difference has statistical significance, which indicates that the application of the long-term glucocorticoid can reduce the skin water content and the skin oil content, and the HDD model is successfully manufactured. The water content and the oil content of the garden burnet ointment in the low, medium and high dose groups and the positive control group are higher than those of the model group, and the difference is statistically significant, so that the garden burnet ointment provided by the application can improve the skin water content and the skin oil content and has the effect of relieving the HDD symptoms.

TABLE 1 influence of Sanguisorbae ointment on skin moisture and oil content of guinea pig HDD

4.2 detection of the Sanguisorba ointment on the guinea pig by the infrared imaging tester before and after the HDD intervention

The infrared imaging tester is adopted to detect the HDD model guinea pigs before and after treatment, and the results are shown in table 2. The model composition model region body temperature is higher than that of the blank composition model region body temperature, and the difference has statistical significance, so that the long-term glucocorticoid application can lead the skin temperature to rise, and the HDD model is successfully manufactured. The temperature of the modeling area of the garden burnet ointment is higher than that of the model group in the high-dose group and the positive control group, and the difference has statistical significance, so that the garden burnet ointment provided by the application can reduce the skin temperature of the modeling area of the HDD and has a relieving effect on the HDD.

Table 2 infrared imaging tester before and after HDD intervention in guinea pigs detected skin temperature in molding zone (x±s, n=8)

4.3 radix Sanguisorbae ointment for dermatoses after guinea pig hormone-dependent dermatitis intervention

Referring to fig. 2, the dermatoscope shows the telangiectasia under the epidermis of guinea pigs in the model group, and the distribution of scales scattered on the epidermis is visible, indicating that HDD model modeling was successful. After the treatment of the sanguisorba ointment low-dose group, scales are obviously reduced, and telangiectasia can still be seen. The scales are obviously resolved in the garden burnet ointment, the high-dose group and the tacrolimus ointment after treatment, and the capillary distention congestion state is improved compared with the model group, so that the garden burnet ointment has the effect of relieving the HDD.

4.4 Dioscorea Sanguisorba ointment for treating histopathological changes after HDD intervention in guinea pigs

Fig. 3 is a schematic diagram of the pathological results of HE staining of skin tissue provided by the application. Referring to fig. 3, the model group (b) shows keratosis with stratum corneum fusion, apparent hyperplasia of epidermis layer, hypertrophic epidermis layer, irregular downward extension of epidermis layer, telangiectasia congestion of dermis layer, infiltration of dermis nipple and lymphocyte surrounding dermis capillary, indicating successful HDD model modeling. Compared with the model group, the skin of the sanguisorba ointment, the high-dose group and the positive control group is improved in the keratoderma structure and the acanthosis and thinned compared with the skin of the model group; the high-dose group of the garden burnet ointment is reduced in inflammatory parts compared with the dose group and the positive control group in the garden burnet ointment, which indicates that the garden burnet ointment has the effect of relieving the HDD.

Based on the results, the sanguisorba ointment Chinese medicinal components have the effects of clearing heat, drying dampness, cooling blood, detoxifying, and have remarkable effects in improving erythema, pimple, swelling, scales, itching, burning sensation, pain, tightness and the like, can effectively relieve inflammatory reaction, reduce exudation, and has remarkable effects in repairing skin barrier function, promoting keratinocyte metabolism and the like. Namely, the composition paste provided by the application has the effect of relieving treatment on HDD.

In a third aspect, the application provides a method for preparing a composition paste, comprising the steps of: mixing white vaseline, lanolin, azone, and glycerol, and heating to dissolve completely to obtain a first composition. Mixing radix Gentianae, radix Sangusorbae, radix Sophorae Flavescentis, cortex moutan, radix Arnebiae and Glycyrrhrizae radix at a predetermined ratio, micronizing, pulverizing, and sieving to obtain Chinese medicinal fine powder. Adding the traditional Chinese medicine fine powder into the first composition, stirring until uniform, standing and cooling to obtain composition paste.

Illustratively, the ingredients are taken at a ratio of 61% white petrolatum, 13% lanolin, 2% azone, and 4% glycerin. Heating to dissolve completely, adding 20% of the Chinese medicinal fine powder, stirring, standing, and cooling to obtain composition paste.

According to the technical scheme, the application provides a composition paste, a preparation method and application thereof. Wherein the composition paste is used for treating hormonal dermatitis. The composition paste is prepared by mixing white vaseline, lanoline, azone, and glycerol, and heating to dissolve completely to obtain a first composition. Then, the gentian, the radix sanguisorbae, the kuh-seng, the moutan bark, the lithospermum and the liquorice are mixed according to a preset proportion, and then are subjected to superfine grinding, and are sieved to obtain the traditional Chinese medicine fine powder. And finally, adding the traditional Chinese medicine fine powder into the first composition, stirring until the mixture is uniform, and standing and cooling to obtain the composition paste. Furthermore, the preparation process of the composition ointment is simple, the safety is high, and the characteristics of external treatment of traditional Chinese medicine are reflected. Meanwhile, the ointment provided by the application fully plays the curative effect of the traditional Chinese medicine, effectively reduces the inflammatory reaction of the hormone-dependent dermatitis, and has obvious effects on repairing the skin barrier function, promoting the metabolism of the horny layer cells and the like.

The above-provided detailed description is merely a few examples under the general inventive concept and does not limit the scope of the present application. Any other embodiments which are extended according to the solution of the application without inventive effort fall within the scope of protection of the application for a person skilled in the art.

Claims (2)

1. A composition paste for the treatment of hormonal dermatitis, characterized by comprising the following components: 10% -40% of traditional Chinese medicine fine powder, 45% -70% of white vaseline, 9% -14% of lanolin, 2% of azone and 4% of glycerin, wherein the traditional Chinese medicine fine powder consists of the following components: gentian: radix Sanguisorbae: radix Sophorae Flavescentis: cortex moutan radicis): radix Arnebiae: the liquorice ratio is 1.5:1.5:0.3:1.0:1.0:1.0.

2. a method for preparing a composition paste according to claim 1, wherein said method comprises the steps of:

mixing white vaseline, lanolin, azone, and glycerol, and heating to dissolve completely to obtain a first composition;

mixing radix Gentianae, radix Sangusorbae, radix Sophorae Flavescentis, cortex moutan, radix Arnebiae and Glycyrrhrizae radix at a preset ratio, micronizing, pulverizing, and sieving to obtain Chinese medicinal fine powder;

adding the traditional Chinese medicine fine powder into the first composition, stirring until uniform, standing and cooling to obtain composition paste.